Clinical Trials at the National Centre for Naturopathic Medicine

Southern Cross University researchers are investigating the efficacy of a herbal product for weight loss in men and women in Australia.

Over a third of the Australian population are considered overweight, and carrying extra weight is a key contributor to increased risk factor for many health conditions. Finding ways to assist people to lose weight is an important global issue and many companies have released products to try to assist. This clinical trial aims to investigate a herbal formula for weight loss in Australia.

Researchers are seeking generally healthy adults aged between 18 and 60 years who are considered to be overweight as classified by a BMI between 25 and 29.9kg/m2 to participate in the trial of the herbal formula.

This trial involves participation in a randomized controlled clinical trial, which means participants will receive either a placebo or an active product. A placebo is a treatment which is designed to have no therapeutic value, but is similar in look, taste and smell to the other treatment being tested.

You can participate from various locations around Australia, including Adelaide, Brisbane, Darwin, Gold Coast, Melbourne, Perth, Sydney, Townsville, and many regional areas - the full list is shown on the survey. You will be required to attend a trial visit every 4 weeks for a total of 16 weeks (4 months).

This clinical trial has approval from the Southern Cross University Human Research Ethics Committee, SCU HREC number: 2021/033

For more information about the clinical trial or to check if you are eligible to participate, please visit the below website. The patient information sheet can be obtained by contacting the lead researcher, Dr Janet Schloss.

Email ncnmtrials@scu.edu.au, or call 0436 101 306 or 02 6626 9255

Researchers are seeking to recruit participants for a new trial from Southern Cross University’s Lismore campus. The trial will explore whether Olive Leaf Extract is safe and effective in improving blood glucose control and quality of life, in adults living with type 2 diabetes.

Regional areas are disproportionately affected by type 2 diabetes, so the trial will be conducted in the Northern Rivers region of New South Wales. The study is a pilot, prospective, randomised placebo-controlled trial, which means participants will be given either the product or a placebo to trial for 24 weeks alongside their usual diabetes care (such as prescribed medications, diet, exercise, appointments) throughout the trial period. Blood samples will be taken at the commencement of the study, as well as halfway through (12 weeks) and again at the completion of the trial (24 weeks).

Researchers are now taking expressions of interest from people over the age of 18 years, who have received a diagnosis of type 2 diabetes, are not currently taking insulin, and are based in the Northern Rivers region of New South Wales. If you would like to find out more about the study and how to get involved, please email ncnmtrials@scu.edu.au.

This clinical trial has approval from the Southern Cross University Human Research Ethics Committee, SCU HREC number: 2022/034

For more information about the clinical trial or to check if you are eligible to participate, please email below. The patient information sheet can be obtained by contacting the lead researcher, Associate Professor Matthew Leach.

Email ncnmtrials@scu.edu.au,
or call 0407 111 561 or 02 6626 9255

Southern Cross University researchers are conducting a clinical trial, examining whether the consumption of Kefir can influence the microbiome.

Kefir is a probiotic dairy beverage that has been consumed for over 2,000 years in the Caucasus region at the border of Europe and Asia. Traditional Kefir is made by taking milk and adding Kefir ‘grains’ which contain a range of symbiotic bacteria and yeast species. Many claims have been made regarding the health benefits of Kefir, however little is known about the effects of Kefir on the microbiome, the collective bacteria in the mouth and gut.

The team are seeking healthy adults with a Body Mass Index between 18.5 and 30 kg/m2, who have no acute or chronic disease. Participants will be required to consume Kefir two times per day for two weeks. Those with gastrointestinal conditions such as Irritable Bowel Syndrome, Ulcerative Colitis or Crohn’s Disease, Celiac disease, lactose intolerance, or dairy allergy, plus those already using fermented foods for health purposes, will not able to participate.

At the beginning of the study, after two weeks of using Kefir, and after another two weeks without Kefir, participants will be asked to fill out questionnaires, and provide oral and stool samples. These samples will be analysed at the Microbiome Research Centre at the University of New South Wales in Sydney.

This clinical trial has been approved by the Southern Cross University Human Research Ethics Committee, #2021/129, and by the University of New South Wales Human Research Ethics Committee, #2021/RL00200.

For more information about the clinical trial or to check if you are eligible to participate, please contact the lead researcher, Associate Professor Romy Lauche PhD.

Email ncnmtrials@scu.edu.au,
or call 02 6626 9255

Southern Cross University researchers are testing a specialised Traditional Chinese Medicine (TCM) herbal formula for safety in healthy adults.

This trial is a phase I safety trial comparing two doses of a specific TCM herbal formulation in tablet form. Participants are separated in to two groups at random and given one of two doses to be taken for 15 days, with blood pathology taken before and after taking the investigational product to monitor for side effects and tolerance.

Each of the herbs in this formulation individually have been found to be safe, and are TGA approved, however the specific formula has not been tested in a clinical trial before. This first step study will examine how well the formula is tolerated by health adults without medical conditions. If this study is successful, in later stages the formulation will be tested in people in further clinical trials.

This clinical trial has approval from the Southern Cross University Human Research Ethics Committee, SCU HREC number: 2021/103.

Participant recruitment has now ended.

Researchers at Southern Cross University are investigating how a single dose of cannabidiol (CBD) is used and excreted in the body in healthy adults.

The trial will be conducted in generally healthy individuals aged 18-60 years old. This is a pharmacokinetic (PK) study of a new drug, which will involve participants taking a dose of CBD (given in a soft gel or liquid) and having blood and urine samples taken to determine how the body handles the substance.

Participants will be required to attend the clinical trial site at the Gold Coast for 9 hours on day one and present for a sample the following day. The process will then be repeated in 2-3 weeks' time with the alternate drug.

This clinical trial has approval from the Southern Cross University Human Research Ethics Committee, SCU HREC number: 2022/099.

Participant recruitment has now concluded.

Southern Cross University researchers are conducting a clinical trial to assess the effectiveness of a herbal formula for women experiencing menopausal symptoms.

Changes in reproductive hormones during the menopausal transition can wreak havoc on womens’ lives, with symptoms such as daytime hot flashes, night sweats, sleep disturbances, weight gain, headaches and mood changes. This herbal formula is currently available on the market. Testimonials by some women have stated that it helped to reduce their menopausal symptoms.

This clinical trial aims to assess the effectiveness of a herbal formula for women experiencing menopausal symptoms. Involvement will include participation in a phase II randomized placebo-controlled clinical trial, which means participants will be given either a placebo or an active product. A placebo is a treatment which is designed to have no therapeutic value, but is similar in look, taste and smell to the other treatment being tested. 

This clinical trial has approval from the Southern Cross University Human Research Ethics Committee, SCU HREC number: 2021/036.

Participant recruitment has now concluded.